Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B

Phase 4

Completed

• Conditions: Chronic Hepatitis B; Late Pregnancy; Transmission; Complication
• Interventions: Drug: Telbivudine; Drug: Lamivudine

• Registration Number: NCT01743079
• Lead Sponsor: Beijing YouAn Hospital

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

Detailed Description

This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA \> 6 log10 c/mL and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no treatment as per their preference. All infants will receive standard immunoprophylaxis. Data is collected from patient records using data extraction forms. Primary endpoints are vertical transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine use.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 700

Inclusion Criteria

1. Age: 20-40 years old
2. HBsAg, HBeAg positive and HBV DNA >6 log10 copies/ml
3. Gestational age: 26-28 weeks with normal fetus
4. Willing to consent for the study

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Exclusion Criteria

1. Elevated ALT
2. Antiviral treatment experience patients
3. Co-infection with HAV, HCV,HDV, HIV
4. Concurrent treatment with immune modulators, cytotoxic drugs, or steroids
5. Clinical signs of threatened miscarriage in early pregnancy
6. Clinical evidence of cirrhosis and/or hepatocellular carcinoma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telbivudine	Telbivudine	Mother receives telbivudine 600mg per day. Infant receives standard immunoprophylaxis
Lamivudine	Lamivudine	Mother receives lamivudine 100mg per day. Infant receives standard immunoprophylaxis.

Primary Outcome Measures

Name	Time	Method
Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child	From gestation week 26 to postpartum week 52

Secondary Outcome Measures

Name	Time	Method
percentage of mothers with serum HBV DNA level reduction, ALT within normal range and HBeAg and/or HBsAg negativity with or without seroconversion	From gestation week 26 to pastpartume week 52

Trial Locations

Locations (1)

Beijing YouAn Hospital; 🇨🇳 Beijing, Beijing, China